DETAILED ACTION
This action is pursuant to claims filed on 2/18/2025. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 4, 5, 7, 8, 9, 11, 12, 14, 15, 16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tam et al. (hereinafter ‘Tam’, US 4274419 A) in view of Avery et al. (hereinafter ‘Avery’, WO 2013177126 A2).
Claim 1: An electrode system for determining impedance ([Col 3, lines 15-47]: device measures impedance), the system comprising:
an abrasion electrode (abrasion electrode 10) configured to be placed at a first skin location of a patient ([Col 3, lines 15-20]: the electrode 10 is secured to the skin of the patient), the abrasion electrode comprises an abrasion component to abrade the first skin location of the patient ([Col 3, lines 15-20]: electrode 10 has a means to abrade the skin of the patient) and an electrode component to electrically engage with the patient ([Col 3, lines 15-20]: electrode element 10 has a sensing element; [Col 7, lines 1-6]: proper electrical contact is made between the electrode 10 and the patient);
a reference electrode ([Col 3, lines 15-47]: reference electrode 16) configured to be placed at a second skin location of the patient ([Col 3, lines 15-47]: reference electrode is secured to the patient; electrodes 10 and 16 are in different locations as seen in Fig. 1);
an impedance determination device (device 12 in Figs. 1 and 2), wherein the impedance determination device monitors an impedance between the abrasion electrode and the reference electrode ([Col 3, lines 15-47]: device 12 continuously measures the impedance between the electrode 10 and the reference electrode 16).
Tam further discloses that the device includes a means for determining when the impedance is lowered to a preset level, at which time the rotation of the pad of the electrode 10 is terminated ([Col 3, lines 15-47]). As broadly claimed, stopping the rotation of the pad of the electrode is a notification to the user that the predetermined impedance has been met and the circuitry that stops the rotation is the user indication device since the claim is not specific to what this indication device is nor what the notification is.
However, while stopping the rotation can be interpreted as the notification and the user indication device can be the portion that terminates the rotation, Tam does not disclose a specific indication such as a light or sound to indicate the impedance range has been met. In order to advance prosecution, a combination teaching the limitation is as follows.
Avery teaches an electrode assembly comprising a plurality of electrodes which contact the subject and a drive element for driving the electrodes towards the subject and an abrasion element adapted to move the electrode to abrade the subject ([Abstract]). The feedback device is arranged to control the drive mechanism such that is drives the electrode to maintain activation of the abrasion element until a target impedance is achieved, similar to the device of Tam ([00011]). The target impedance is determined as the impedance between each electrode and the reference electrode within a predetermined bounds ([00012]). The feedback device measures the impedance and when the impedance reaches a predetermined threshold value, the abrasion is stopped ([00054]). This is the same feedback process as Tam, stopping the abrasion once the impedance threshold has been met. The feedback and impedance threshold system ensure that the contact impedance is maintained at a low enough level to produce high-quality measurement data ([00069]). In addition to the internal feedback system, Avery also teaches that a visual feedback of contact impedance can be included, such as a Green LED, which would indicate to the clinician that good-contact has been achieved ([00070]). Incorporating an LED indicator that alerts the clinician once the threshold impedance has been met would be or routine skill in the art and lead to the obvious benefit of alerting the clinician when good contact quality is achieved. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the visual feedback system of Avery with the device of Tam such that, in addition to stopping the abrasion upon reaching the threshold impedance, a visual signal is provided to the clinician that the threshold impedance has been achieved and thus the electrode is in good contact with the skin of the subject.
Regarding claim 2, the Tam/Avery combination discloses the electrode system of Claim 1, further comprising an abrasion motor (motor 20) connected to the abrasion component of the abrasion electrode ([Col 5, lines 50-60]: when the switch is actuated, the one-shot drives a current amplifier causing current to flow through the motor 20 to rotate the rotatably mounted pad of the electrode 10), wherein the abrasion motor provides movement of the abrasion component to abrade ([Col 6, lines 40-45]: Rotation of the motor 20 rotates the pad in the electrode 10 to abrade skin beneath the electrode 10).
Regarding claim 4, the Tam/Avery combination discloses the electrode system of Claim 1, wherein the impedance determination device monitors the impedance between the abrasion electrode and the reference electrode during placement of the abrasion electrode ([Col 3, lines 15-47]: the device 12 rotates the mounted pad of the electrode 10 while continuously measuring the impedance between the electrode 10 and the reference electrode 16).
Regarding claim 5, the Tam/Avery combination discloses the electrode system of Claim 1, wherein the abrasion electrode and the reference electrode are connected via a lead-wire ([Col 3, lines 15-47]: a leadwire 14 extends from the device 12 to a reference electrode 16 and the electrode 10 is connected to the device 12, thus the lead connects the electrode 10 and the reference electrode 16 – this is consistent with the instant application wherein the lead wire connects to the device housing which then connects to the abrasion electrode), wherein the impedance between the abrasion electrode and the reference electrode is monitored via the lead-wire ([Col 4, lines 15-42]: the leadwire 14 plugs into jack 50 and the impedance measuring circuitry receives a signal indicative of the actual impedance between the electrode 10 and the reference electrode 16 – thus the impedance is monitored via the leadwire since the leadwire is what is electrically connecting the reference electrode to the impedance measuring circuitry).
Regarding claim 7, the Tam/Avery combination discloses the electrode system of Claim 1, further comprising an additional abrasion electrode configured to be placed at a third skin location of the patient, wherein the additional abrasion electrode comprises an abrasion component to abrade the third skin location of the patient and an electrode component to electrically engage with the patient, wherein the impedance determination device monitors an impedance between the additional abrasion electrode and the reference electrode ([Col 4, lines 65-68]: electrode 10 is an “applied electrode”; [Col 6, lines 45-55]: rotation of the abrasive pad of the electrode 10 is terminated once the desired impedance is reached and the device is used to prepare the skin for another applied electrode – the applied electrode is the same type of electrode as electrode 10 as described above, thus it inherently has the same parts to abrade and electrically engage with the patient; [Col 2, lines 18-68]: a large number of monitoring electrodes are applied to the skin of the patient with the sensing element of each of the monitoring electrodes moved relative to the skin in contact with the sensing element by the skin preparation device while the impedance between the abrading tip or sensing element and the reference electrode is continuously measured; the device 12 inherently works in the same manner when applying the additional electrodes; multiple electrodes are applied to different parts of the body as seen in Fig. 1).
Regarding independent claim 8, Tam discloses method of using an impedance determination electrode system, the method comprising:
providing an abrasion electrode (abrasion electrode 10 is provided) configured to be placed at a first skin location of a patient ([Col 3, lines 15-20]: the electrode 10 is secured to the skin of the patient), the abrasion electrode comprises an abrasion component to abrade the first skin location of the patient ([Col 3, lines 15-20]: electrode 10 has a means to abrade the skin of the patient) and an electrode component to electrically engage with the patient ([Col 3, lines 15-20]: electrode element 10 has a sensing element; [Col 7, lines 1-6]: proper electrical contact is made between the electrode 10 and the patient);
providing a reference electrode ([Col 3, lines 15-47]: reference electrode 16 is provided) configured to be placed at a second skin location of the patient ([Col 3, lines 15-47]: reference electrode is secured to the patient; electrodes 10 and 16 are in different locations as seen in Fig. 1);
providing an impedance determination device (device 12 in Figs. 1 and 2 is provided) to monitor an impedance between the abrasion electrode and the reference electrode ([Col 3, lines 15-47]: device 12 continuously measures the impedance between the electrode 10 and the reference electrode 16).
Tam further discloses that the device includes a means for determining when the impedance is lowered to a preset level, at which time the rotation of the pad of the electrode 10 is terminated ([Col 3, lines 15-47]). As broadly claimed, stopping the rotation of the pad of the electrode is a notification to the user that the predetermined impedance has been met and the circuitry that stops the rotation is the user indication device since the claim is not specific to what this indication device is nor what the notification is.
However, while stopping the rotation can be interpreted as the notification and the user indication device can be the portion that terminates the rotation, Tam does not disclose a specific indication such as a light or sound being provided to indicate the impedance range has been met. In order to advance prosecution, a combination teaching the limitation is as follows.
Avery teaches an electrode assembly comprising a plurality of electrodes which contact the subject and a drive element for driving the electrodes towards the subject and an abrasion element adapted to move the electrode to abrade the subject ([Abstract]). The feedback device is arranged to control the drive mechanism such that is drives the electrode to maintain activation of the abrasion element until a target impedance is achieved, similar to the device of Tam ([00011]). The target impedance is determined as the impedance between each electrode and the reference electrode within a predetermined bounds ([00012]). The feedback device measures the impedance and when the impedance reaches a predetermined threshold value, the abrasion is stopped ([00054]). This is the same feedback process as Tam, stopping the abrasion once the impedance threshold has been met. The feedback and impedance threshold system ensure that the contact impedance is maintained at a low enough level to produce high-quality measurement data ([00069]). In addition to the internal feedback system, Avery also teaches that a visual feedback of contact impedance can be included, such as a Green LED, which would indicate to the clinician that good-contact has been achieved ([00070]). Providing an LED indicator that alerts the clinician once the threshold impedance has been met would be or routine skill in the art and lead to the obvious benefit of alerting the clinician when good contact quality is achieved. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the visual feedback system of Avery with the method of Tam such that, in addition to stopping the abrasion upon reaching the threshold impedance, a visual signal is provided to the clinician that the threshold impedance has been achieved and thus the electrode is in good contact with the skin of the subject.
Regarding claim 9, the Tam/Avery combination discloses the method of Claim 8, further comprising connecting an abrasion motor to the abrasion component of the abrasion electrode ([Col 5, lines 50-60]: when the switch is actuated, the one-shot drives a current amplifier causing current to flow through the motor 20 to rotate the rotatably mounted pad of the electrode 10 – thus the motor is connected to the pad of the electrode), wherein the abrasion motor provides movement of the abrasion component to abrade ([Col 6, lines 40-45]: Rotation of the motor 20 rotates the pad in the electrode 10 to abrade skin beneath the electrode 10).
Regarding claim 11, the Tam/Avery combination discloses the method of Claim 8, wherein the impedance determination device monitors the impedance between the abrasion electrode and the reference electrode during placement of the abrasion electrode ([Col 3, lines 15-47]: the device 12 rotates the mounted pad of the electrode 10 while continuously measuring the impedance between the electrode 10 and the reference electrode 16).
Regarding claim 12, the Tam/Avery combination discloses the method of Claim 8, further comprising connecting the abrasion electrode and the reference electrode via a lead-wire ([Col 3, lines 15-47]: a leadwire 14 extends from the device 12 to a reference electrode 16 and the electrode 10 is connected to the device 12, thus the lead connects the electrode 10 and the reference electrode 16 – this is consistent with the instant application wherein the lead wire connects to the device housing which then connects to the abrasion electrode), wherein the impedance between the abrasion electrode and the reference electrode is monitored via the lead-wire ([Col 4, lines 15-42]: the leadwire 14 plugs into jack 50 and the impedance measuring circuitry receives a signal indicative of the actual impedance between the electrode 10 and the reference electrode 16 – thus the impedance is monitored via the leadwire since the leadwire is what is electrically connecting the reference electrode to the impedance measuring circuitry).
Regarding claim 14, the Tam/Avery combination discloses the method of Claim 8, further comprising providing an additional abrasion electrode configured to be placed at a third skin location of the patient, wherein the additional abrasion electrode comprises an abrasion component to abrade the third skin location of the patient and an electrode component to electrically engage with the patient, wherein the impedance determination device monitors an impedance between the additional abrasion electrode and the reference electrode ([Col 4, lines 65-68]: electrode 10 is an “applied electrode”; [Col 6, lines 45-55]: rotation of the abrasive pad of the electrode 10 is terminated once the desired impedance is reached and the device is used to prepare the skin for another applied electrode – the applied electrode is the same type of electrode as electrode 10 as described above, thus it inherently has the same parts to abrade and electrically engage with the patient; [Col 2, lines 18-68]: a large number of monitoring electrodes are applied to the skin of the patient with the sensing element of each of the monitoring electrodes moved relative to the skin in contact with the sensing element by the skin preparation device while the impedance between the abrading tip or sensing element and the reference electrode is continuously measured; the device 12 inherently works in the same manner when applying the additional electrodes; multiple electrodes are applied to different parts of the body as seen in Fig. 1).
Regarding independent claim 15, Tam discloses a method of using an impedance determination electrode system, the method comprising:
positioning an abrasion electrode at a first skin location of a patient ([Col 3, lines 15-20]: the electrode 10 is secured to the skin of the patient), the abrasion electrode comprises an abrasion component to abrade the first skin location of the patient ([Col 3, lines 15-20]: electrode 10 has a means to abrade the skin of the patient) and an electrode component to electrically engage with the patient ([Col 3, lines 15-20]: electrode element 10 has a sensing element; [Col 7, lines 1-6]: proper electrical contact is made between the electrode 10 and the patient);
positioning a reference electrode at a second skin location of the patient ([Col 3, lines 15-47]: reference electrode is secured to the patient; electrodes 10 and 16 are in different locations as seen in Fig. 1);
monitoring, via an impedance determination device, an impedance between the abrasion electrode and the reference electrode ([Col 3, lines 15-47]: device 12 continuously measures the impedance between the electrode 10 and the reference electrode 16).
Tam further discloses that the device includes a means for determining when the impedance is lowered to a preset level, at which time the rotation of the pad of the electrode 10 is terminated ([Col 3, lines 15-47]). As broadly claimed, stopping the rotation of the pad of the electrode is a notification to the user that the predetermined impedance has been met since the claim is not specific to what the notification is.
However, while stopping the rotation can be interpreted as the notification, Tam does not disclose a specific indication such as a light or sound to indicate the impedance range has been met. In order to advance prosecution, a combination teaching the limitation is as follows.
Avery teaches an electrode assembly comprising a plurality of electrodes which contact the subject and a drive element for driving the electrodes towards the subject and an abrasion element adapted to move the electrode to abrade the subject ([Abstract]). The feedback device is arranged to control the drive mechanism such that is drives the electrode to maintain activation of the abrasion element until a target impedance is achieved, similar to the device of Tam ([00011]). The target impedance is determined as the impedance between each electrode and the reference electrode within a predetermined bounds ([00012]). The feedback device measures the impedance and when the impedance reaches a predetermined threshold value, the abrasion is stopped ([00054]). This is the same feedback process as Tam, stopping the abrasion once the impedance threshold has been met. The feedback and impedance threshold system ensure that the contact impedance is maintained at a low enough level to produce high-quality measurement data ([00069]). In addition to the internal feedback system, Avery also teaches that a visual feedback of contact impedance can be included, such as a Green LED, which would indicate to the clinician that good-contact has been achieved ([00070]). Incorporating an LED indicator that alerts the clinician once the threshold impedance has been met would be or routine skill in the art and lead to the obvious benefit of alerting the clinician when good contact quality is achieved. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the visual feedback system of Avery with the method of Tam such that, in addition to stopping the abrasion upon reaching the threshold impedance, a visual signal is provided to the clinician that the threshold impedance has been achieved and thus the electrode is in good contact with the skin of the subject.
Regarding claim 16, the Tam/Avery combination discloses the method of Claim 15, further comprising causing an actuation of an abrasion motor connected to the abrasion component of the abrasion electrode ([Col 5, lines 50-60]: when the switch is actuated, the one-shot drives a current amplifier causing current to flow through the motor 20 to rotate the rotatably mounted pad of the electrode 10), wherein the abrasion motor provides movement of the abrasion component to abrade ([Col 6, lines 40-45]: Rotation of the motor 20 rotates the pad in the electrode 10 to abrade skin beneath the electrode 10).
Regarding claim 18, the Tam/Avery combination discloses the method of Claim 15, wherein the impedance between the abrasion electrode and the reference electrode is monitored during placement of the abrasion electrode ([Col 3, lines 15-47]: the device 12 rotates the mounted pad of the electrode 10 while continuously measuring the impedance between the electrode 10 and the reference electrode 16).
Regarding claim 20, the Tam/Avery combination discloses the method of Claim 15, further comprising:
positioning an additional abrasion electrode at a third skin location of the patient, wherein the additional abrasion electrode comprises an abrasion component to abrade the third skin location of the patient and an electrode component to electrically engage with the patient ([Col 4, lines 65-68]: electrode 10 is an “applied electrode”; [Col 6, lines 45-55]: rotation of the abrasive pad of the electrode 10 is terminated once the desired impedance is reached and the device is used to prepare the skin for another applied electrode); and
monitoring, via the impedance determination device, an impedance between the additional abrasion electrode and the reference electrode ([Col 2, lines 18-68]: a large number of monitoring electrodes are applied to the skin of the patient with the sensing element of each of the monitoring electrodes moved relative to the skin in contact with the sensing element by the skin preparation device while the impedance between the abrading tip or sensing element and the reference electrode is continuously measured; the device 12 inherently works in the same manner when applying the additional electrodes which means that the impedance is monitored while applying the additional electrodes; multiple electrodes are applied to different parts of the body as seen in Fig. 1).
Claim(s) 3, 10, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over the Tam/Avery combination as applied to claims 1, 8, and 15, respectively, in further view of Liley et al. (hereinafter ‘Liley’, US 20130317380 A1).
Regarding claim 3, the Tam/Avery combination discloses the electrode system of Claim 1 as described above. Tam further discloses that the device includes a means for determining when the impedance is lowered to a preset level and the preset impedance level can be set by the user to ([Col 3, lines 15-47]; [Col 5, lines 18-65]).
However, the combination is silent to the predetermined range of impedance being between 5 kiloohms and 10 kiloohms.
Liley teaches a method for displaying the activity of the brain by first obtaining an EEG signal ([0008]). The device comprises electrodes and the system measures the impedance between each respective electrodes and compares it to a reference value ([0070]). The diagnostic interface includes a flag corresponding to each respective electrode, and a flag for a particular electrode is colored if the electrode has impedance outside a range (e.g. if it is greater than 5-10 kOhms) necessary for accurate performance ([0070]). Thus, Liley teaches that an impedance range of 5-10kOhms is an impedance range necessary for accurate performance. Since the Tam/Avery combination teaches that the user sets the desired impedance threshold, it would be obvious to one of ordinary skill in the art to set that threshold to be a range of 5-10kOhm since that impedance ranges indicates accurate performance. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the impedance range of 5-10kOHm with the system of the Tam/Avery combination such that the user is notified with the impedance falls within the range of 5-10kOhm, which indicates that the impedance has been lowered to a level necessary for accurate performance as taught by Liley.
Regarding claim 10, the Tam/Avery combination discloses the method of Claim 8 as described above. Tam further discloses that the device includes a means for determining when the impedance is lowered to a preset level and the preset impedance level can be set by the user to ([Col 3, lines 15-47]; [Col 5, lines 18-65]).
However, the combination is silent to the predetermined range of impedance being between 5 kiloohms and 10 kiloohms.
Liley teaches a method for displaying the activity of the brain by first obtaining an EEG signal ([0008]). The device comprises electrodes and the system measures the impedance between each respective electrodes and compares it to a reference value ([0070]). The diagnostic interface includes a flag corresponding to each respective electrode, and a flag for a particular electrode is colored if the electrode has impedance outside a range (e.g. if it is greater than 5-10 kOhms) necessary for accurate performance ([0070]). Thus, Liley teaches that an impedance range of 5-10kOhms is an impedance range necessary for accurate performance. Since the Tam/Avery combination teaches that the user sets the desired impedance threshold, it would be obvious to one of ordinary skill in the art to set that threshold to be a range of 5-10kOhm since that impedance ranges indicates accurate performance. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the impedance range of 5-10kOHm with the method of the Tam/Avery combination such that the user is notified with the impedance falls within the range of 5-10kOhm, which indicates that the impedance has been lowered to a level necessary for accurate performance as taught by Liley.
Regarding claim 17, the Tam/Avery combination discloses the method of Claim 15 as described above. Tam further discloses that the device includes a means for determining when the impedance is lowered to a preset level and the preset impedance level can be set by the user to ([Col 3, lines 15-47]; [Col 5, lines 18-65]).
However, the combination is silent to the predetermined range of impedance being between 5 kiloohms and 10 kiloohms.
Liley teaches a method for displaying the activity of the brain by first obtaining an EEG signal ([0008]). The device comprises electrodes and the system measures the impedance between each respective electrodes and compares it to a reference value ([0070]). The diagnostic interface includes a flag corresponding to each respective electrode, and a flag for a particular electrode is colored if the electrode has impedance outside a range (e.g. if it is greater than 5-10 kOhms) necessary for accurate performance ([0070]). Thus, Liley teaches that an impedance range of 5-10kOhms is an impedance range necessary for accurate performance. Since the Tam/Avery combination teaches that the user sets the desired impedance threshold, it would be obvious to one of ordinary skill in the art to set that threshold to be a range of 5-10kOhm since that impedance ranges indicates accurate performance. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the impedance range of 5-10kOHm with the system of the Tam/Avery combination such that the user is notified with the impedance falls within the range of 5-10kOhm, which indicates that the impedance has been lowered to a level necessary for accurate performance as taught by Liley.
Claim(s) 6, 13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over the Tam/Avery combination as applied to claims 1, 8, and 15, respectively, in further view of Naier et al. (hereinafter ‘Naier’, US 20190048193 A1).
Regarding claim 6, the Tam/Avery combination discloses the electrode system of Claim 1 as described above. Tam further states that the reference electrode can be a conventional type electrode ([Col 3, lines 15-47]).
However, Tam does not explicitly state that the reference electrode comprises a hydrogel pad.
Naier teaches a medical electrode coated with a hydrogel comprising cross-linked copolymer chains, wherein some of the repetitive units have a special function profile ([0001]). The electrode taught by Naier can be used in a variety of scenarios such as a defibrillation electrode, ECG electrode, EEG electrode, TENS electrode, iontophoresis electrode, neutral electrode, or wound electrode ([0077]). The hydrogel of the electrode provides an improved electrical profile, adhesion profile, and swelling behavior ([0006]). Since Tam discloses that the reference electrode can be any conventional electrode, it would be of routine skill in the art to utilize the electrode of Naier for the reference electrode since doing so would ensure that the reference electrode has a hydrogel and all of the benefits of such a hydrogel. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the electrode of Naier as the reference electrode of the disclosed system such that the reference electrode has a hydrogel pad which provides for an improved electrical profile, adhesion profile, and swelling behavior.
Regarding claim 13, the Tam/Avery combination discloses the method of Claim 8 as described above. Tam further states that the reference electrode can be a conventional type electrode ([Col 3, lines 15-47]).
However, Tam does not explicitly state that the reference electrode comprises a hydrogel pad.
Naier teaches a medical electrode coated with a hydrogel comprising cross-linked copolymer chains, wherein some of the repetitive units have a special function profile ([0001]). The electrode taught by Naier can be used in a variety of scenarios such as a defibrillation electrode, ECG electrode, EEG electrode, TENS electrode, iontophoresis electrode, neutral electrode, or wound electrode ([0077]). The hydrogel of the electrode provides an improved electrical profile, adhesion profile, and swelling behavior ([0006]). Since Tam discloses that the reference electrode can be any conventional electrode, it would be of routine skill in the art to utilize the electrode of Naier for the reference electrode since doing so would ensure that the reference electrode has a hydrogel and all of the benefits of such a hydrogel. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the electrode of Naier as the reference electrode of the disclosed method such that the reference electrode has a hydrogel pad which provides for an improved electrical profile, adhesion profile, and swelling behavior.
Regarding claim 19, the Tam/Avery combination discloses the method of Claim 15 as described above. Tam further states that the reference electrode can be a conventional type electrode ([Col 3, lines 15-47]).
However, Tam does not explicitly state that the reference electrode comprises a hydrogel pad.
Naier teaches a medical electrode coated with a hydrogel comprising cross-linked copolymer chains, wherein some of the repetitive units have a special function profile ([0001]). The electrode taught by Naier can be used in a variety of scenarios such as a defibrillation electrode, ECG electrode, EEG electrode, TENS electrode, iontophoresis electrode, neutral electrode, or wound electrode ([0077]). The hydrogel of the electrode provides an improved electrical profile, adhesion profile, and swelling behavior ([0006]). Since Tam discloses that the reference electrode can be any conventional electrode, it would be of routine skill in the art to utilize the electrode of Naier for the reference electrode since doing so would ensure that the reference electrode has a hydrogel and all of the benefits of such a hydrogel. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the electrode of Naier as the reference electrode of the disclosed method such that the reference electrode has a hydrogel pad which provides for an improved electrical profile, adhesion profile, and swelling behavior.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/W.M./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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